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CA2497128A1 - Microprotrusion arrays and methods for using same to deliver substances into tissue - Google Patents

Microprotrusion arrays and methods for using same to deliver substances into tissue Download PDF

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Publication number
CA2497128A1
CA2497128A1 CA002497128A CA2497128A CA2497128A1 CA 2497128 A1 CA2497128 A1 CA 2497128A1 CA 002497128 A CA002497128 A CA 002497128A CA 2497128 A CA2497128 A CA 2497128A CA 2497128 A1 CA2497128 A1 CA 2497128A1
Authority
CA
Canada
Prior art keywords
microprotrusion
array
microprotrusions
platen
skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002497128A
Other languages
French (fr)
Other versions
CA2497128C (en
Inventor
Alexander G. Lastovich
Jason B. Alarcon
John P. Dekker, Iii
M. Ishaq Haider
John A. Mikszta
Frank E. Martin
Scott A. O'connor
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2497128A1 publication Critical patent/CA2497128A1/en
Application granted granted Critical
Publication of CA2497128C publication Critical patent/CA2497128C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0038—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046—Solid microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Claims (14)

1. A microprotrusion array for the rotational delivery of a fluid substance into tissue, said array comprising:
at least one platen, said platen comprising a microprotrusion surface, and a platen edge having a thickness, wherein said microprotrusion surface is suitable for attaching a plurality of microprotrusions thereon or therein;
a plurality of microprotrusions attached in or on said microprotrusion surface of said platen, wherein each of said microprotrusions comprises at least one scraping edge; and at least one fluid substance retaining means, said substance retaining means selected from the group consisting of inter-microprotrusion spacing, one or more recesses between said microprotrusions, one or more areas devoid of microprotrusions, one or more areas of reduced microprotrusion density, one or more areas of microprotrusions attached to the platen in a pattern adapted to direct said substance toward the interior of said array, one or more channels in the platen microprotrusion attachment surface, and combinations thereof.
2. The array of claim 1, wherein the pattern of attached microprotrusions adapted to direct said substance comprises areas of differing microprotrusion densities.
3. The array of claim 1, wherein each of said microprotrusions further comprises:
a microprotrusion base having a base center and a base circumference;
a microprotrusion tip; and a longitudinal axis having a microprotrusion length from said base center to said microprotrusion tip.
4. The array of claim 1, wherein said microprotrusion surface comprises a plurality of channels disposed between said microprotrusion bases.
5. The array of claim 1, wherein said microprotrusion lengths vary from said platen edge to the array center.
6. The array of claim 3 wherein the thickness of said platen edge varies from the outer most portion of said platen edge to the center of the platen.
7. The array of claim 1 wherein the at least one platen is integral with a surface of a rotary abrader device.
8. The array of claim 1 further comprising two or more platens with microprotrusions attached thereto or thereon.
9. The array of claim 8 wherein the at least one fluid substance retaining means is disposed between said two or more platens.
10. A method for delivering substance into skin via an abrader device comprising the steps of:
positioning at least one array of abrading microprotrusions at a delivery site on the skin of a subject, wherein said at least one array is attached to an abrader device comprising an abrader housing and a mechanical rotating means adapted to rotate said array;
mechanically rotating the array of microprotrusions against the skin of said subject with sufficient force to disrupt and substantially penetrate the stratum corneum of the subject without piercing said stratum corneum;
applying a liquid substance to the skin of said subject at the delivery site prior, to or simultaneously with said mechanical rotation of said array; and removing said abrader device from the delivery site, wherein said at least one microprotrusion array further comprises at least one platen, said platen comprising a microprotrusion surface having a plurality of microprotrusions attached therein or thereon, and a platen edge having a thickness, said microprotrusion array further comprising at least one fluid substance retaining means, said substance retaining means selected from the group consisting of intra-microprotrusion spacing, one or more recesses between said microprotrusions, one or more areas devoid of microprotrusions, one or more areas of reduced microprotrusion density, one or more areas of microprotrusions attached to the platen in a pattern adapted to direct said substance toward the interior of said array, one or more channels in the platen microprotrusion attachment surface, and combinations thereof.
11. The method according to claim 10, wherein said abrader housing surrounds the array of microprotrusions, and wherein the abrader housing comprises at least one housing element selected from the group consisting of an upper housing, a lower housing, an inner housing, and an outer housing, and combinations thereof and wherein at least one of said at least one housing element remains stationary during the mechanical rotation of the microprotrusion array, and when said abrader device is positioned against the skin of the subject, said at least one stationary housing component reduces the tendency of the skin at the delivery site to flex during mechanical rotation of the microprotrusion array against the skin at the delivery site.
12. The method according to claim 10, further comprising the step of applying the abrader device with a predetermined amount of force to the delivery site on the skin of the subject during said mechanical rotation.
13. The method according to claim 11, wherein the abrader housing releasably attaches to the skin of the subject at the delivery site and holds said skin taut as said microprotrusion array is mechanically rotated.
14. The method according to claim 10, wherein the substance is applied on the skin of the patient at the delivery site after the abrader device is positioned at the delivery site.
CA2497128A 2002-08-29 2003-08-27 Microprotrusion arrays and methods for using same to deliver substances into tissue Expired - Fee Related CA2497128C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US40669402P 2002-08-29 2002-08-29
US60/406,694 2002-08-29
PCT/US2003/026812 WO2004020015A2 (en) 2002-08-29 2003-08-27 Microprotrusion arrays and methods for using same to deliver substances into tissue

Publications (2)

Publication Number Publication Date
CA2497128A1 true CA2497128A1 (en) 2004-03-11
CA2497128C CA2497128C (en) 2011-10-18

Family

ID=31978342

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2497103A Expired - Fee Related CA2497103C (en) 2002-08-29 2003-08-27 Microabrader with controlled abrasion features
CA2497128A Expired - Fee Related CA2497128C (en) 2002-08-29 2003-08-27 Microprotrusion arrays and methods for using same to deliver substances into tissue
CA2497154A Expired - Fee Related CA2497154C (en) 2002-08-29 2003-08-27 Substance delivery via a rotating microabrading surface

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2497103A Expired - Fee Related CA2497103C (en) 2002-08-29 2003-08-27 Microabrader with controlled abrasion features

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2497154A Expired - Fee Related CA2497154C (en) 2002-08-29 2003-08-27 Substance delivery via a rotating microabrading surface

Country Status (7)

Country Link
US (5) US7422567B2 (en)
EP (4) EP1531896B1 (en)
JP (3) JP4429907B2 (en)
AU (3) AU2003270011B8 (en)
CA (3) CA2497103C (en)
ES (4) ES2617576T3 (en)
WO (3) WO2004020015A2 (en)

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